(24 days)
No
The description focuses on hardware components, fluid control, pressure monitoring, and standard software control logic. There is no mention of AI, ML, or any learning algorithms.
Yes
The device is described as "intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT)". These actions directly treat medical conditions, defining it as a therapeutic device.
No
The device is intended for surgical resection and coagulation of tissue, not for diagnosis.
No
The device description clearly lists multiple hardware components (Controller, Resectoscope, Fluid Control Set, Video Control Unit, Roll Stand, Footswitch, Waste Management Tubing, Tissue Catch, Waste Management Bags) that are integral to the system's function. While software is mentioned as controlling some functions, it is part of a larger hardware system.
Based on the provided information, the Veloxion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope." This describes a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The components described are all involved in the surgical procedure itself (resectoscope, controller, fluid control, video control, etc.). While there are accessories for handling waste after it's removed from the patient (tissue catch, waste bags), their purpose is for collection and disposal, not for diagnostic testing of the waste material.
- Lack of Diagnostic Testing: There is no mention of the device performing any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status. The system is used for the physical removal of tissue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Veloxion System's function is surgical intervention, not diagnostic testing.
N/A
Intended Use / Indications for Use
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
Product codes
FJL, KQT, GEI
Device Description
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resectoscope
- Veloxion Fluid Control Set
- Veloxion Video Control Unit
- Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- Tissue Catch: For collection of gross resected tissue pieces for pathology.
- Waste Management Bags: To provide bags for final collection of outflow.
The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:
- The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
- The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
- The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
- The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, bladder, intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained urologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates.
Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA 's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K190099, K062720, K042523, K162979
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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June 13, 2019
Corinth MedTech, Inc. Sandeep Saboo Vice President. Ouality Assurance & Regulatory Affairs 1601 S. De Anza Blvd., Suite 200 Cupertino, CA 95014
K191341 Re: Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL, KQT, GEI Dated: May 15, 2019 Received: May 20, 2019
Dear Sandeep Saboo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or (301) 796-7100).
Sincerely,
for Glenn B. Bell. Ph.D. Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191341
Device Name Veloxion System
Indications for Use (Describe)
The Veloxion System is intended for use by trained urologists for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas and bladder tumors (TURBT) via suction channel under continuous flow conditions following resection using a bipolar resectoscope.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K191341: 510(k) Summary I.
Submitter Information
| Submitter name: | Corinth MedTech, Inc.
1601 S. De Anza Blvd, Suite 200
Cupertino, CA 95014 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sandeep Saboo
Vice President, Regulatory Affairs and Quality Assurance
Phone: (408) 996-2517
Fax: (408) 996-0621 |
| Date Prepared: | 14 May 2019 |
II. Product Classification
| Device Name: | Veloxion System | |
|---|---|---|
| Common Name: | Resectoscope | Subject Device |
| Regulation: | 21 CFR 876.1500 | |
| Regulation Name: | Endoscope and accessories | |
| Class: | II | |
| Product Code: | FJL | |
| Additional Product Codes: | KQT, GEI |
III. Predicate Devices
The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed:
| Predicate | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| Primary Predicate | ||||
| Predicate #1 | Corinth MedTech, Inc. | Veloxion System | K190099 | March 15, 2019 |
| Predicate #2 | ||||
| (predicate system) | Richard Wolf Medical | |||
| Instruments | ||||
| Corporation | S-Line Bipolar Resectoscope | |||
| & ERBE ESU | K062720 | March 22, 2007 | ||
| Predicate #3 | ||||
| (predicate system) | Richard Wolf Medical | |||
| Instruments | ||||
| Corporation | Resection Master & ERBE | |||
| ESU | K042523 | March 18, 2005 | ||
| Predicate #4 | ||||
| (predicate system) | Corinth MedTech, Inc. | Veloxion System | K162979 | March 24, 2017 |
Predicate devices have not been the subject of a design related recall.
IV. Device Description
The Veloxion System consists of the following components:
- · Veloxion Controller (with Integrated Fluid Control)
- o Footswitch
- · Veloxion Resectoscope
- · Veloxion Fluid Control Set
- Veloxion Video Control Unit
- Veloxion Roll Stand
4
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- · Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- · Tissue Catch: For collection of gross resected tissue pieces for pathology.
- · Waste Management Bags: To provide bags for final collection of outflow.
The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:
- · The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
- · The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
- · The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
- The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
V. Indications for Use
There is no difference in the indications for use for the modified Veloxion System (subject device) when compared to the predicate devices.
| Comparison of Indications for Use | |
|---|---|
| Device | Indications For Use |
| Modified | |
| Veloxion System | |
| (Subject Device) | The Veloxion System is intended for use by trained urologists for endoscopically |
| controlled tissue chip resection and coagulation, and removal of prostate adenomas and | |
| bladder tumors (TURBT) via suction channel under continuous flow conditions following | |
| resection using a bipolar resectoscope. | |
| Veloxion System | |
| K190099 | |
| (Primary Predicate) | |
| Predicate #1 | The Veloxion System is intended for use by trained urologists for endoscopically |
| controlled tissue chip resection and coagulation, and removal of prostate adenomas via | |
| suction channel under continuous flow conditions following resection using a bipolar | |
| resecting device. |
Comparison of Indications for Use
5
Veloxion System
SPECIAL 510(k) Premarket Notification
| Device | Indications For Use |
|---|---|
| Predicate #2 | |
| K062720 | |
| (Predicate system) | S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue |
| using 0.9% NaCl solution (saline) as the irrigation medium. | |
| For Urology: | |
| Urological surgical procedures involving the ablation or removal of soft tissue and where | |
| associated hemostasis is required. | |
| Transurethral resection of the prostate (TURP) and bladder neck. | |
| Transurethral resection of the bladder tumors (TURBT) | |
| Transurethral incision of the prostate. | |
| Coagulation of bleeding in the lower urinary tract. | |
| For Gynecology: | |
| Tissue cutting, removal, and desiccation as required or encountered in gynecologic | |
| hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, | |
| adhesions, septa, and benign conditions requiring endometrial ablation. | |
| Excision of intrauterine myomas. | |
| Excision of intrauterine polyps. | |
| Lysis of intrauterine septa. | |
| Endometrial ablation. | |
| Predicate #3 | |
| K042523 | |
| (Predicate system) | The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically |
| controlled tissue chip resection and removal of intrauterine polyps, intrauterine myomas or | |
| prostate adenomas via suction channel under continuous flow conditions following | |
| resection using a high-frequency electrode with a Resectoscope. | |
| Predicate #4 | |
| K162979 | |
| (Predicate system) | The Veloxion System is intended for endoscopically controlled tissue chip resection and |
| coagulation and removal of prostate adenomas via suction channel under continuous flow | |
| conditions following resection using a bipolar resecting device. |
VI. Comparison of Technological Characteristics with the Predicate Device
The subject Veloxion System and the previously cleared predicate devices have the same or similar technological characteristics (see Table 1) in terms of basic operating principle and basic design features.
6
Veloxion System SPECIAL 510(k) Premarket Notification
| Table 1: Comparison of subject Veloxion System and predicate: | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | --------------------------------------------------------------- |
| Technological Characteristics | VELOXION SYSTEM
(Subject) | VELOXION SYSTEM
(Predicate System)
K190099 & K162979 | Richard Wolf S-Line
Resectoscope System
(Predicate System)
K062720 | Richard Wolf Resection Master
System
(Predicate System)
K042523 |
|--------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Energy Type: | Radiofrequency, bipolar | Radiofrequency, bipolar | Radiofrequency, bipolar | Radiofrequency, bipolar |
| RF Functions: | Cut, Coagulation | Cut, Coagulation | Cut, Coagulation | Cut, Coagulation |
| Able to Set & Monitor Cavity
Pressure? | YES | YES | YES | YES |
| Irrigation fluid: | Saline | Saline | Saline | Saline |
| Outer Sheath Working Length: | 220mm | K190099: 220mm
K162979: 193mm | 186mm | 186mm |
| Outer Sheath OD: | 25Fr (8.3mm) | K190099: 25Fr (8.3mm)
K162979: 26Fr (8.6mm) | 27Fr (9.0mm) | 27Fr (9.0mm) |
| Inner Sheath OD: | 19.5 Fr (6.5mm) | K190099: 19.5 Fr (6.5mm)
K162979: N/A | 21 Fr (7mm) | N/A |
| Max Electrode Extension outside
Sheath: | 20mm | K190099: 20mm
K162979: 23mm | 21mm | 21mm |
| Electrode Wire OD: | 0.019" | K190099: 0.019"
K162979: 0.015" | 0.010inch to 0.015inch | 0.010inch to 0.015inch |
| Electrode Movement: | Linear Oscillation at 3000cpm | K190099:
Linear Oscillation at 3000cpm
K162979:
Linear Oscillation at 1000cpm | Stationary on the distal end | Stationary on the distal end |
7
Corinth MedTech, Inc.
There are minor differences in the technological characteristics between the subject Veloxion System and the predicates. The minor differences do not raise new or different questions of safety and effectiveness for the intended use of the device as it pertains to the expansion of the indications for use.
VII. Performance Data
No new performance testing was required to establish substantially equivalence. Results of tests in reviewed as part of clearance of K190099 and K162979 with comparison testing to the predicates (predicate Veloxion System and Richard Wolf Resectoscope) support substantial equivalence to the identified predicates.
- . Software Verification Testing was performed using the same protocol reviewed as part of K 190099 for all steps affected by the change and documentation updated per FDA 's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
VIII. Conclusions
The subject Veloxion System is considered substantially equivalent and as safe and effective as the identified predicate devices (predicate systems).